Everyone’s Talking about Biosecurity

BY CARRIE D. WOLINETZ

Sens. Joseph Lieberman, I-Conn., and Susan Collins, R-Maine, have introduced the Weapons of Mass Destruction Preparedness and Prevention Act of 2009 (SB-1649). The bill is based on the Weapons of Mass Destruction Commission report, “World at Risk,” and is focused on preventing a biological attack.

If enacted, the legislation would impose a new series of controlled pathogen regulations, in addition to the current select agent regulations, that would create a Tier 1 group of pathogens based on their likelihood of being weaponized. In addition, the bill would require containment labs and other facilities dealing with pathogens not on the select agent list to register with the federal government and would grant greater authority to the Department of Homeland Security in regulating pathogen control and laboratory biosecurity. Other portions of the WMD act relate to emergency response, public communication in the event of an attack and increasing biosecurity and biosafety internationally.

At a U.S. Senate Homeland Security and Government Affairs Committee hearing, WMD commission chairs and former Sens. Bob Graham and Jim Talent testified that the nation was in imminent danger of a biological attack and the most likely threat was that of a “rogue scientist” acting from within a U.S. laboratory. Another witness, from the Government Accountability Office, presented information from a July GAO report showing that only three of the five biosafety Level Four facilities described possessed 15 factors related to perimeter security.

The Federation of American Societies for Experimental Biology has provided informal comments on the legislation and is working to develop more formal comments through our Biosecurity Subcommittee of the Science Policy Committee. FASEB is concerned about both the proposed increased authority for DHS and the implementation of overlapping and potentially burdensome regulations, with little improvement in security. Currently, there is no House equivalent of the legislation.

However, Senate HSGAC members are not the only ones in Washington focused on biosecurity. Two additional hearings on high-containment labs and biosecurity were held the same day by the House Energy and Commerce Committee and the Senate Judiciary Committee. These hearings primarily were focused on a second GAO report on the proliferation of high-containment labs that took place after the influx of federal biodefense funding in response to the anthrax attacks of 2001. The GAO report recommended the federal government inventory and develop centralized oversight of all high-containment laboratories as well as develop standards for biosafety, design and operation of those labs.

In addition to the GAO report, several other high-profile communications related to pathogen control and laboratory biosafety and biosecurity have been or are expected to be released in the coming weeks: a trans-agency task force report on biosafety; the findings of the Executive Order Working Group on Strengthening the Biosecurity of the United States, on which FASEB and the Association of American Medical Colleges provided extensive input and a National Research Council report on pathogen control and laboratory biosecurity.

The NRC study, “Responsible Research with Biological Select Agents and Toxins,” which cited FASEB’s statements and recommendations on biosecurity, is more moderate in its proposed actions than the Lieberman-Collins bill. It suggests that the current level of screening is sufficient and does not warrant additional screening processes, although there is a recommendation to alter the current appeals process. In addition, the report recommends increased training in biosafety and bioethics for lab personnel with access to select agents. The report also calls for the creation of a national advisory board on select agents and toxins, made up primarily of scientists, to promulgate best practices, provide guidance on implementation of select agent regulations and promote harmonization of regulatory policies and practices. Other suggestions include revising the current inventory requirements, stratifying the select agent list and regulations, developing minimum physical security standards for high-containment laboratories and providing additional training for inspectors.

Carrie D. Wolinetz is director of scientific affairs and public relations for the Office of Public Affairs at FASEB. She can be reached at cwolinetz@faseb.org.